PLAVIX SUMMARY
PLAVIX (clopidogrel bisulfate) is an inhibitor of ADP-induced platelet aggregation acting by direct inhibition of adenosine diphosphate (ADP) binding to its receptor and of the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex.
PLAVIX (clopidogrel bisulfate) is indicated for the reduction of thrombotic events as follows:
- Recent MI, Recent Stroke or Established Peripheral Arterial Disease
For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, PLAVIX has been shown to reduce the rate of a combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death.
- Acute Coronary Syndrome
For patients with acute coronary syndrome (unstable angina/non-Q-wave MI) including patients who are to be managed medically and those who are to be managed with percutaneous coronary intervention (with or without stent) or CABG, PLAVIX has been shown to decrease the rate of a combined endpoint of cardiovascular death, MI, or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia.
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NEWS HIGHLIGHTSMedia Articles Related to Plavix (Clopidogrel)
New Anti-Clotting Drug Beats Plavix
Source: MedicineNet Atrial Fibrillation Specialty [2009.08.31]
Title: New Anti-Clotting Drug Beats Plavix
Category: Health News
Created: 8/30/2009 8:10:00 AM
Last Editorial Review: 8/31/2009
Plavix Plus Heartburn Drugs May Hike Heart Risk
Source: MedicineNet pantoprazole Specialty [2009.01.29]
Title: Plavix Plus Heartburn Drugs May Hike Heart Risk
Category: Health News
Created: 1/29/2009 2:00:00 AM
Last Editorial Review: 1/29/2009
Published Studies Related to Plavix (Clopidogrel)
Randomized controlled trial of aspirin and clopidogrel versus aspirin and placebo on markers of smooth muscle proliferation before and after peripheral angioplasty. [2009.10]
OBJECTIVE: In peripheral arterial disease (PAD) patients, a limiting factor in the success of percutaneous transluminal angioplasty (PTA) is the development of restenosis secondary to vascular smooth muscle cell (SMC) proliferation. Following endothelial damage and platelet activation, there is release of factors and adhesion molecules which affect SMC proliferation. The aim of this study was to determine the effect of combination antiplatelet therapy (clopidogrel and aspirin compared with aspirin and placebo) on the ability of plasma from PAD patients undergoing PTA to stimulate SMCs in vitro. We further aimed to investigate the effect of combination treatment on the levels of circulating adhesion molecules and factors, which are known to mediate SMC proliferation in experimental models... CONCLUSIONS: This is the first study to show in-vitro ERK 1/2 activation (a surrogate marker of SMC proliferation) increases post-PTA. Combination antiplatelet therapy had no significant effect on this, although it did reduce PDGF. Further work is required to evaluate potential therapeutic treatments, which may reduce peripheral PTA-induced smooth muscle cell activation. CLINICAL RELEVANCE: High rates of restenosis remain the major limitation of peripheral arterial angioplasty and stenting.The restenotic lesion occurs secondary to platelet activation, released circulating factors, and subsequent smooth musclecell proliferation and migration into the intima. Methods to limit the restenotic lesion are poorly understood. This paperinvestigates the effect of PTA on smooth muscle cell activation and the release of factors in plasma which mediate SMCproliferation. It also examines the effect of combination antiplatelet therapy as a potential therapeutic strategy.
Comparison of omeprazole and pantoprazole influence on a high 150-mg clopidogrel maintenance dose the PACA (Proton Pump Inhibitors And Clopidogrel Association) prospective randomized study. [2009.09.22]
OBJECTIVES: This study sought to compare the effect of 2 proton pump inhibitors (PPIs) on platelet response to clopidogrel after coronary stenting for non-ST-segment elevation acute coronary syndrome (NSTE ACS). BACKGROUND: Use of omeprazole has been reported to significantly decrease the clopidogrel antiplatelet effect because of cytochrome P450 interaction. Because all PPIs are metabolized by CYP2C19, but to a varying degree, we hypothesized that the reported negative omeprazole-clopidogrel drug interaction may not be caused by a class effect... CONCLUSIONS: The present findings suggest the preferential use of pantoprazole compared with omeprazole in patients receiving clopidogrel to avoid any potential negative interaction with CYP2C19.
Ticagrelor versus clopidogrel in patients with acute coronary syndromes. [2009.09.10]
BACKGROUND: Ticagrelor is an oral, reversible, direct-acting inhibitor of the adenosine diphosphate receptor P2Y12 that has a more rapid onset and more pronounced platelet inhibition than clopidogrel... CONCLUSIONS: In patients who have an acute coronary syndrome with or without ST-segment elevation, treatment with ticagrelor as compared with clopidogrel significantly reduced the rate of death from vascular causes, myocardial infarction, or stroke without an increase in the rate of overall major bleeding but with an increase in the rate of non-procedure-related bleeding. (ClinicalTrials.gov number, NCT00391872.) 2009 Massachusetts Medical Society
Week-long high-maintenance dose clopidogrel regimen achieves better platelet aggregation inhibition than a standard loading dose before percutaneous coronary intervention: results of a double-blind, randomized clinical trial. [2009.08]
BACKGROUND: Adequate platelet inhibition before percutaneous coronary intervention (PCI) reduces periprocedural and long-term ischemic complications. Reduced response to clopidogrel has been associated with subsequent major adverse cardiovascular events. Strategies to optimize platelet inhibition pre-PCI are under investigation. This study evaluated the effect on platelet aggregation of four different dosing regimens of clopidogrel given before elective PCI in a randomized, prospective, double-blind, and placebo-controlled design... CONCLUSIONS: A 300-mg loading dose of clopidogrel followed by 150 mg daily for 1 week prior to coronary angiography provides more effective platelet inhibition, as defined by LTA, compared to the standard 300-mg loading dose regimen at the time of coronary intervention.
Relation of genetic polymorphisms in the cytochrome P450 gene with clopidogrel resistance after drug-eluting stent implantation in Koreans. [2009.07.01]
Clopidogrel is a prodrug that has to be converted to an active metabolite by hepatic cytochrome P450 (CYP) isoenzymes to inhibit platelet aggregation... In conclusion, CYP2C19*3 single-nucleotide polymorphisms is an independent risk factor of clopidogrel resistance in Korean subjects with coronary artery disease.
Clinical Trials Related to Plavix (Clopidogrel)
Pharmacodynamics of CGT 2168 Compared With Plavix® [Active, not recruiting]
CG106 is a Phase I open-label, randomized, multiple-dose, two-way crossover study to
characterize the pharmacodynamics and pharmacokinetics of the investigational fixed-dose
combination product CGT 2168 (clopidogrel, 75 mg and omeprazole, 20 mg) relative to Plavix®
(clopidogrel, 75 mg).
Healthy volunteer subjects will undergo two dosing periods. In each 7-day dosing period,
subjects will receive oral doses of study drug consisting of open-label CGT 2168 or Plavix®
in the order determined by the randomization schedule. Each period of dose administration
will be separated by a two-week washout period. Study exit will occur 1 week after Dosing
Period 2. The expected total duration of participation is 8 weeks (56 days), including a
screening visit on or within 21 days prior to enrollment.
On the day before Day 1 and Day 7 in each dosing period, subjects will be admitted to the
Phase I unit. Blood samples to determine ADP-induced platelet aggregation will be collected
pre-dose on Day 1 and 2 h after dosing on Day 7. Plasma concentrations of clopidogrel parent
and clopidogrel carboxylic acid metabolite will also be measured pre-dose on Day 1 and
pre-dose and serially after dosing on Day 7.
Effect of Different Dosing Regimens of Clopidogrel Before Elective Percutaneous Coronary Intervention (PCI) on Platelet Function [Completed]
Adequate platelet inhibition before percutaneous coronary intervention (PCI) reduces
peri-procedural and long-term ischemic complications. Documented reduced response to
clopidogrel has been associated with subsequent major adverse cardiovascular events.
Strategies to optimize platelet inhibition pre-PCI are under investigation.
This study sought to evaluate the effect on platelet aggregation of four different dosing
regimens of clopidogrel given before elective PCI.
Clopidogrel Reloading in Clopidogrel Resistant Patients With ACS [Completed]
Laboratory clopidogrel resistance is associated with adverse atherothrombotic events in
patients with coronary artery disease. In the proposed study we wish to prospectively assess
the effect of reloading with 600 mg clopidogrel, and administer maintenance treatment with
clopidogrel 150 mg/day for one month in a group of acute myocardial infarction (AMI) patients
who demonstrate non-responsiveness to clopidogrel.
Fasting Study of Clopidogrel Bisulfate Tablets 75 mg to Plavix® Tablets 75 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's clopidogrel
bisulfate 75 mg tablets to Bristol-Myers Squibb/Sanofi's Plavix® 75 mg tablets following a
single, oral 75 mg (1 x 75 mg) dose administered under fasting conditions.
Food Study of Clopidogrel Bisulfate Tablets 75 mg to Plavix® Tablets 75 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's clopidogrel
bisulfate 75 mg tablets to Bristol-Myers Squibb/Sanofi's Plavix® 75 mg tablets following a
single, oral 75 mg (1 x 75 mg) dose administered under fed conditions.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Plavix has an overall score of 7. The effectiveness score is 8 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
| | Plavix review by 50 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Considerably Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | replacement of femoral vein in leg |
| Dosage & duration: | | 75 mg taken once a day for the period of 2 months |
| Other conditions: | | roceasa |
| Other drugs taken: | | asprin | | |
Reported Results |
| Benefits: | | This is supposed to thin the blood. I don't know how you measure this. |
| Side effects: | | The side effect that I noticed was EXTENSIVE bruising wherever the skin is struck or bumped into something. |
| Comments: | | After taking this drug for about a month and a half, I fell down some cement stairs quite dramatically. The next day I was sore, as can be expected. But I also had HUGE bruises in the spots where I guess I made the most contact or the most severe impact. (I'm lucky I didn't crack my head open or break something!)One bruise was about 6 inches by 6 inches. |
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Page last updated: 2009-10-20
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